The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of two vaccines for active immunization against the H5N1 subtype of the influenza A virus, which causes avian influenza or bird flu.
Celldemic is a zoonotic H5N1 influenza vaccine intended for active immunization of adults and infants from 6 months of age in the event of influenza outbreaks originating from animals, including situations where public health authorities foresee a potential pandemic.
Incellipan is a pandemic preparedness H5N1 vaccine and is intended for deployment solely upon the official declaration of a flu pandemic. After identifying the virus strain responsible, the manufacturer can incorporate it into the authorized vaccine. They then need to seek authorization for that vaccine as the "final" pandemic vaccine. The accelerated authorization process for the final pandemic vaccine is facilitated by the prior assessment of its quality, safety, and efficacy with other potential pandemic strains.
Most cases of avian influenza in humans have been due to transmission from birds. But there has also been transmission from other sources, such as a contaminated environment. Whereas some avian viruses do not cause disease in humans or are known to only cause mild disease, others, like the H5N1 subtype of the influenza A virus, are known to cause severe disease or even death.
Symptoms range from asymptomatic or mild cases, with conjunctivitis or mild flulike upper respiratory symptoms, to severe conditions requiring hospitalization, such as pneumonia. Commonly reported symptoms include fever or feeling feverish, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, fatigue, and shortness of breath or difficulty breathing. Less frequent symptoms include diarrhea, nausea, vomiting, or seizures.
Celldemic will be available as a 7.5-µg per 0.5-mL dose suspension for injection. It comprises hemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures, along with the adjuvant M59C.1.
Celldemic induces a strong immune response in adults and children 3 weeks after 2 doses, administered at a 3-week interval, as measured by hemagglutination inhibition titers against H5N1. Common side effects in adults include pain at the injection site, fatigue, headache, malaise, myalgia, and arthralgia. In children aged 6-18 years, prevalent side effects include injection site pain, myalgia, fatigue, malaise, headache, loss of appetite, nausea, and arthralgia. In children 6 months to less than 6 years old, tenderness at the injection site, irritability, sleepiness, changes in eating habits, and fever are the most common side effects.
Incellipan will be offered as a 7.5-µg per 0.5 mL dose suspension for injection. Similar to Celldemic, it contains hemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures and the adjuvant M59C.1.
Incellipan also triggers a robust immune response in adults and children 3 weeks after 2 doses administered with a 3-week interval, measured by hemagglutinin inhibition titers against H5N1. Common side effects align with those of Celldemic, including pain at the injection site, fatigue, headache, malaise, myalgia, arthralgia, and other age-specific reactions.
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